Compositions for disinfection of skin and mucous membrane

ABSTRACT

A process and compositions for disinfecting the skin, hands and mucous membrane. The compositions contain an optical brightener and exhibit intense fluorescence in the visible wavelength range on exposure to UV light and thus permit simple monitoring of the treated skin or mucous membrane surfaces for ensuring complete disinfection, but without exhibiting the disadvantages associated with the use of conventional dyes, such as discoloration of the skin and articles.

CROSS REFERENCE TO RELATED APPLICATION

This is the 35 USC 371 national stage of international applicationPCT/EP97/06041 filed on Oct. 28, 1997, which designated the UnitedStates of America.

FIELD OF INVENTION

The invention relates to compositions, containing optical brighteners,such as compositions for disinfecting the hands, skin and mucousmembrane.

BACKGROUND OF THE INVENTION

Before operations, the skin or mucous membrane in the region of theoperation area is treated with antiseptic disinfectants. Here, it isnecessary to ensure complete wetting of the epithelium in order toguarantee complete disinfection. For this reason, intensely colouredpreparations which permit visual monitoring of the application of thedisinfectant are usually used for disinfecting the skin and mucousmembrane.

However, the disadvantage of these compositions is that colour changesof the skin which may occur during the operation, such as, for example,pallor as a result of depletion of blood or a blue colour due toinadequate oxygen saturation of the blood, for example in cardiacinsufficiency or pulmonary diseases, are masked by the dye, and anynecessary measures on the part of the surgeon are thus delayed or evencompletely prevented. In addition, the pronounced adhesion of the dyesto the skin, in particular of patients, is found to be very troublesome.Moreover, clothing, operating tables, floors, equipment, etc. soiled bythe dyes used are difficult to clean.

SUMMARY OF THE INVENTION

It is the object of the present invention to provide a process fordisinfecting a surface which do not have the abovementioneddisadvantages by the application of a composition on said surface ormucous membrane surface, in order to be able to ensure completedisinfection of the operating area.

This object is achieved by compositions which contain at least oneoptical brightener provided that the composition does not contain anyfluoro-aliphatic surfactant nor reducing agent selected from the classof hydrazine and hydroxylamine and alkali metal salts of oxygen acids ofdivalent sulfur and tetravalent sulfur.

Optical brighteners are compounds which are caused to fluoresce in thevisible wavelength range by ultraviolet radiation, i.e. substances whichabsorb ultraviolet radiation and emit longer-wavelength, visibleradiation.

Preferably used optical brighteners are the same substances which arealso used in detergents for brightening the laundry or in variouspersonal hygiene preparations for increasing the brilliance of, forexample, soaps and cosmetic formulations. Particularly preferred opticalbrighteners are stilbene compounds, such as, for example,diaminostilbenedisulphonic acid, coumarin derivatives, such as, forexample, 4-methyl-7-diethylaminocoumarin, 1,3-diaryldipyrazolinederivatives, such as, for example,1,3-diphenyl-4-methyl-5-alkylpyrazoline, naphthalimide derivatives, suchas, for example, N-methyl-4-methoxynaphthalimide, and benzoxazolederivatives, such as, for example,1,2-bis(5-methylbenzoxazol-2-yl)ethylene. Pyrazoline derivatives (e.g.Hostalux® PN, from Hoechst), cationic benzimidazole derivatives (e.g.Blankophor® ACR, from Bayer) and anionic distearylbiphenyl derivatives(e.g. Blankophor® VPSP 20006, from Bayer) are very particularlypreferred.

Particularly suitable are of course those optical brighteners which areused for brightening wool, such as, for example, Blankophor® ACR andBlankophor® VPSP, since this natural fibre has considerable similaritywith human skin. However, brighteners for other fibres, such as, forexample, polyamide, paper, polyester, polyacrylonitrile and cotton, arealso suitable.

The use of optical brighteners permits the preparation of disinfectantswhich contain a substantially lower dye concentration and preferably nocustomary dyes at all. In contrast to the conventional, intenselycoloured disinfectants, they are therefore also suitable fordisinfecting the hands as well as equipment and work surfaces, providingfor the first time a possibility for monitoring the completeness ofwetting in these areas too.

The excitation wavelength for the disinfectants according to theinvention depends on the optical brightener used and is preferably inthe range of customary UV lamps, i.e. preferably in the range from about300 to 400 nm.

Skin surfaces treated with the disinfectants according to the inventiontherefore fluoresce brightly on exposure to a UV lamp, permitting simplemonitoring of the surfaces treated with the compositions and henceguaranteeing complete disinfection of the desired surface. In normaldaylight, the disinfectants according to the invention and hence alsothe treated skin areas and all other articles, such as clothing, floorsand equipment, which have come into contact with the compositions arenot coloured.

A particular advantage of the optical brighteners used according to theinvention is that, in contrast to many traditional dyes, they are notabsorbed, therefore do not have systemic activity and are hencetoxicologically safe. Furthermore, they have no sensitizing properties.

The optical brighteners are used in an amount such that, on exposure toUV light of a suitable wavelength, a clear distinction between treatedand untreated surfaces is possible. For this purpose, the brightenersare typically used in an amount of from 0.0001 to 3% by weight,preferably in an amount of from 0.001 to 2.0% by weight, based on thetotal amount of disinfectant.

The concentration of the brightener furthermore depends on the intendeduse of the composition. While washing hand disinfectants frequentlyrequire higher concentrations, for example in the range from 0.2 to 1.0%by weight, since these compositions are for the most part rinsed offagain after use, lower concentrations of from 0.005 to 0.5% by weightand in particular from 0.05 to 0.3% by weight may be entirely sufficientin the case of other compositions.

The disinfectants according to the invention contain, as furthercomponents, conventional constituents such as antimicrobial activeingredients, liquid carriers and excipients. Suitable compositions areknown from the prior art.

Antimicrobial active ingredients include, quaternary compounds,guanidine derivatives, phenol derivatives iodine-eliminating compounds,aromatics alcohols, aliphatic alcohols, peroxide compounds such ashydrogene peroxide or organic peroxyacid compounds such as peraceticacid.

Excipients include anionic surfactants, cationic surfactants ornon-ionic surfactants such as alkylether sulfates, alkylbenzenesulfonates, alkylsulfates, fatty acid esters, fattyacid alcohols,polyalkoxylated derivatives of fatty alcohols or of fatty acids,alkylpolyglycosides, betaines, sultaine, imidazoline and theirderivatives, and fatty quaternary amonium salts.

Excipients also include thickening agents.

Compositions for disinfecting the skin and mucous membrane preferablycontain one or more of the following constituents:

Antimicrobial active ingredients Quaternary compounds from 0.005 to 50%by weight; Guanidine derivatives from 0.1 to 10% by weight; Phenolderivatives from 0.02 to 5% by weight; Iodine-eliminating from 0.5 to20% compounds by weight; Peroxide compounds from 0.001 to 10% by weight;Aromatic alcohols from 0.5 to 5% by weight and/or from 1 to 15% Alcoholsby weight.

Excipients

Surfactants (preferably cocamidopropylbetaine, sulphosuccinate, sodiumlauryl ether sulphate) and/or

Stabilizers (preferably H₂O₂, buffer substances).

Compositions for disinfecting the skin preferably contain one or more ofthe following constituents:

Antimicrobial active ingredients Alcohols from 5 to 96% by weight;Quartenary compounds from 0.05 to 50% by weight; Guanidine derivativesfrom 0.1 to 10% by weight; Phenol derivatives from 0.01 to 10% byweight; Iodine-eliminating from 0.5 to 20% compounds by weight; Peroxidecompounds from 0.001 to 10% by weight; Aromatic alcohols from 0.5 to 10%by weight; Fatty acids from 0.1% to 5% by weight and/or from 0.1 to 5%Hydroxy carboxylic acids by weight.

Excipients

Stabilizers (preferably H₂O₂).

Compositions for disinfecting the hands preferably contain one or moreof the following constituents:

Antimicrobial active ingredients Alcohols from 5 to 96% by weight;Quaternary compounds from 0.05 to 50% by weight; Guanidine derivativesfrom 0.1 to 10% by weight; Phenol derivatives from 0.01 to 10% byweight; Peroxide compounds from 0.001 to 10% by weight; Aromaticalcohols from 0.5 to 10% by weight; Fatty acids from 0.1 to 5% by weightand/or from 0.1 to 5% Hydroxy carboxylic acids by weight.

Excipients

Superfatting agents (preferably triglycerides, fatty alcohols, fattyacids),

Humectants (preferably sorbitol solution, 1,2-propylene glycol, PEGderivatives, sodium lactate)

Thickeners (preferably hydroxyethylcellulose, hydroxy-propyl-cellulose,xanthans, polyacrylates)

Perfume and/or

Dyes.

Washing hand disinfectants preferably contain one or more of thefollowing constituents:

Antimicrobial active ingredients Alcohols from 5 to 30% by weight;Quaternary compounds from 0.1 to 20% by weight; Guanidine derivativesfrom 0.1 to 10% by weight; Phenol derivatives from 0.5 to 5% by weight;Iodine-eliminating from 0.5 to 20% compounds by weight; Peroxidecompounds from 0.001 to 10% by weight and/or from 0.5 to 10% Aromaticalcohols by weight.

Excipients

Surfactants (preferably cocamidopropylbetaine, sulpho-succinate, sodiumlauryl ether sulphate)

Stabilizers (preferably H₂O₂)

Thickeners (preferably hydroxyethylcellulose)

Dyes and/or

Perfume.

Preferred antimicrobial active ingredients are:

Quaternary compounds: Octenidine dihydrochloride, benzalkonium chloride;Guanidine derivatives: Chlorhexidine dihydro- chloride; chlorhexidinedigluconate; Phenol derivatives: 2-Biphenylol; Iodine-eliminatingPolyvinylpyrrolidone- compounds: iodine (PVP-iodine); Peroxidecompounds: H₂O₂; Aromatic alcohols: Phenoxyethanol, phenethyl alcohol,benzyl alcohol; Alcohols: Ethanol, 1-propanol, 2-propanol;Hydroxycarboxylic acids: Lactic acid; Fatty acids: Undecylenic acid.

Compositions as herebefore described, are also an object of the presentinvention.

DETAILED DESCRIPTION OF THE INVENTION

The invention is illustrated in more detail below with reference toembodiments.

EXAMPLES Example 1 Composition for Disinfecting the Skin and MucousMembrane

A composition containing the following constituents is prepared as thecomposition for disinfecting the skin and mucous membrane:

Octenidine dihydrochloride 0.10% by weight Phenoxyethanol 2.00% byweight Blankophor ® ACR 0.2% by weight Cocamidopropylbetaine solution30% 2.00% by weight Sodium gluconate 1.00% by weight Water to make up to100%

Phenoxyethanol is initially introduced into a first vessel andoctenidine dihydrochloride is dissolved therein. In a second vessel,sodium gluconate is added to water and stirred until the sodiumgluconate has completely dissolved. Thereafter, thecocamidopropylbetaine solution is added and stirred in. The twosolutions are then combined and are stirred until a clear solution isobtained. Finally, Hostalux® PN liquid is added and stirring is carriedout again until a clear solution is obtained.

Example 2 Composition for Disinfecting the Hands

A composition containing the following constituents is prepared as thecomposition for disinfecting the hands:

Ethyl alcohol 80.00% by weight Isopropyl myristate 1.00% by weightSorbitol solution 0.50% by weight Hostalux ® PN liquid (dispersion 0.1%by weight of a pyrazoline derivative) Perfume 0.05% by weight Water tomake up to 100%

Ethanol and water are mixed, sorbitol solution is added and stirring iscarried out. Thereafter, isopropyl myristate and perfume are added andthe mixture is stirred until a clear solution is obtained. Hostalux® PNliquid is then added and stirring is carried out again until a clearsolution is obtained.

Example 3 Composition for Disinfecting the Skin

A composition containing the following constituents is prepared as thecomposition for disinfecting the skin:

Isopropyl alcohol 45.00% by weight 1-Propanol 10.00% by weightHostalux ® PN liquid (dispersion 0.1% by weight of a pyrazolinederivative) Water to make up to 100%

Isopropyl alcohol, 1-propanol and water are mixed, Hostalux® PN liquidis added and stirring is carried out until a clear solution is obtained.

Example 4 Washing Hand Disinfectant

A composition containing the following constituents is prepared as thewashing composition for disinfecting the hands:

1-Propanol 10.00% by weight Isopropyl alcohol 8.00% by weight2-Biphenylol 2.00% by weight Cocamidopropylbetaine 20.00% by weightsolution 30% Hostalux ® PN liquid (dispersion 0.50% by weight of apyrazoline derivative) Perfume 0.20% by weight Hydroxyethylcellulose1.00% by weight Water to make up to 100%

Isopropyl alcohol and 1-propanol are mixed, and thehydroxyethylcellulose is added with stirring. Thereafter, water is addedto the mixture and 2-biphenylol, cocamidopropylbetaine solution andperfume are stirred into the mixture in the stated order. Hostalux® PNliquid is then added and stirring is carried out until a clear solutionis obtained.

All mixtures show intense fluorescence on exposure to UV light having awavelength of 366 nm (UV lamp: CAMAG Reprostar II or DESAGA HeidelbergUVIS universal unit).

What is claimed is:
 1. Process for disinfecting a skin surface or mucoussurface, which comprises applying to the surface an effective amount ofa disinfecting composition which contains at least an optical brightenerand optionally a humectant selected from the group consisting ofsorbitol solution, 1-2 propylene glycol, PEG derivatives and sodiumlactate, provided that said composition does not contain anyfluoroaliphatic surfactant nor reducing agent selected from the class ofhydrazine and hydroxylamine and alkali metal salts of oxygen acids ofdivalent sulfur and tetravalent sulfur.
 2. The process according toclaim 1, wherein the optical brightener is selected from the groupconsisting of stilbene compounds, coumarin derivatives,1-3-diarylpyrazoline derivatives, naphthalimide derivatives, andbenzoxazole derivatives.
 3. The process according to claim 2, whereinthe optical brightener is selected from the group consisting ofdiaminostilbenedisulfonic acid, 4-methyl-7-diethyl aminocoumarin,1,3-diphenyl-4-methyl-5-alkylpyrazoline, and1,2-bis(5-methylbenzoxazol-2-yl)ethylene.
 4. The process according toclaim 1, wherein the composition further contains one or moreantimicrobial active ingredients selected from the group consisting ofquaternary compounds, guanidine derivatives, iodine eliminatingcompounds, peroxide compounds, aromatic alcohols, non-aromatic alcohols,fatty acids, hydroxy carboxylic acids, phenol derivatives, and organicperoxyacid compounds.
 5. The process according to claim 1, wherein thecomposition further contains one or more excipients selected from thegroup consisting of surfactants, humectants, thickeners, perfumes, andsuperfatting agents.
 6. The process according to claim 1, wherein thecomposition further contains one or more stabilizers.
 7. The processaccording to claim 4, wherein the composition contains between 0.1 and1% by weight of octenidine dihydrochloride.
 8. The process according toclaim 1, wherein the surface to be disinfected is the surface of hands.9. The process according to claim 1, wherein the composition containsfrom 0.0001% to 3.0% by weight of optical brightener.
 10. The processaccording to claim 9, wherein the composition contains from 0.001 to 2%by weight of optical brightener.
 11. A disinfecting composition fordisinfecting a skin surface or mucous surface, which comprises at least0.0001% to 3.0% by weight of an optical brightener and optionally ahumectant selected from the group consisting of sorbitol solution, 1-2propylene glycol, PEG derivatives and sodium lactate, provided that saidcomposition does not contain any fluoroaliphatic surfactant norreduction agent selected from the class of hydrazine and hydroxylamineand alkali metal salts of oxygen acids of divalent sulfur andtetravalent sulfur.
 12. The composition according to claim 11, whereinthe composition contains from 0.001% to 2.0% by weight of the opticalbrightener.
 13. The composition according to claim 11, wherein theoptical brightener is selected from the group consisting of stilbenecompounds, coumarin derivatives, 1-3-diarylpyrazoline derivatives,naphthalimide derivatives, and benzoxazole derivatives.
 14. Thecomposition according to claim 11, wherein the composition furthercontains one or more antimicrobial active ingredients selected from thegroup consisting of quaternary compounds, guanidine derivatives, iodineeliminating compounds, peroxide compounds, aromatic alcohols,non-aromatic alcohols, fatty acids, hydroxy carboxylic acids, phenolderivatives, and organic peroxyacid compounds.
 15. The compositionaccording to claim 11, wherein the composition further contains one ormore excipients selected from the group consisting of surfactants,humectants, thickeners, perfumes, and superfatting agents.